GW Pharmaceuticals PLC- ADR (NASDAQ:GWPH), a biopharmaceutical company focused on discovering, developing and commercializing novel therapeutics from its proprietary cannabinoid product platform, announces financial results for the fourth quarter and twelve months ended 30 September 2015.

“This last year has seen GW maintain a rapid pace in the progress of our pediatric epilepsy research program, including the start and completion of recruitment of multiple Phase 3 trials for Epidiolex, and the expansion of our expanded access program which has continued to yield promising safety and efficacy data,” stated Justin Gover, GW’s Chief Executive Officer. “We expect to carry this momentum through 2016 with top-line data from four Epidiolex pivotal trials, our first NDA filing, build-out of our U.S. commercial organization, and ongoing data read-outs from a number of clinical pipeline programs.”

2015 Highlights

  • Epidiolex® (CBD) childhood epilepsy program:
    • Company sponsored Phase 3 development programs in Dravet syndrome and Lennox-Gastaut syndrome
      • First Phase 3 Dravet syndrome trial fully enrolled above original target sample size (120 randomized) data expected Q1 2016
      • First LGS Phase 3 trial fully enrolled above original target sample size (171 randomized). Data expected Q2 2016
      • Second LGS Phase 3 trial fully enrolled above original target sample size. ( > 210 expected to randomize). Data expected Q2 2016
      • Second Phase 3 Dravet syndrome trial ongoing. Data expected mid 2016
      • NDA submission with FDA expected Q4 2016
      • Phase 3 Tuberous Sclerosis Complex trial expected to commence Q1 2016
      • Additional clinical development for Epidiolex beyond initial three indications expected to commence in H2 2016
    • Expanded access program:
      • Separate data update announcement issued today at the American Epilepsy SocietyDecember 2015 Annual Meeting
      • Approximately 350 children on treatment at 32 U.S. clinical sites
      • Over 850 children authorized for treatment by FDA under Expanded Access Treatment INDs and 6 U.S. State programs
    • Strategic agreement with Government of New South Wales in Australia to conduct Epidiolex and CBDV clinical trials
    • CBD and CBDV patent portfolio strengthened
  • Advanced clinical programs in multiple cannabinoid pipeline product candidates:
    • Phase 2a CBD schizophrenia study data shows positive proof-of-concept with a reassuring safety profile
    • Phase 2 CBDV epilepsy study in adults underway with data expected H2 2016
    • Neonatal Hypoxic-Ischemic Encephalopathy (NHIE) IV CBD Phase 1 clinical program expected to commence in H1 2016
      • Orphan Drug and Fast Track Designations granted from FDA and EMA
    • Clinical trials within the field of autism spectrum disorders expected to commence in H2 2016
    • Phase 1b/2a study for the treatment of Recurrent Glioblastoma Multiforme (GBM) fully enrolled with data expected in mid-2016
      • Orphan Drug Designation granted from FDA
    • Phase 2 study in type-2 diabetes fully enrolled with data expected mid 2016
    • Phase 2 study of Sativex in spasticity due to cerebral palsy ongoing with data expected mid 2016
  • Pre-clinical progress addressing a number of areas of unmet need including autism spectrum disorders, duchenne muscular dystrophy, glioma, ovarian and pancreatic cancers, and chemotherapy-induced cachexia
  • U.S. operations established in Carlsbad, California
    • GW’s CEO, Justin Gover, relocates to the U.S.
    • Seasoned industry executive Julian Gangolli appointed as President, North America
    • Epilepsy specialist team build-out underway

Financial Highlights

  • Balance sheet further strengthened with successful NASDAQ follow-on offering raising net proceeds after expenses of £127.5 million ($193.3 million)
  • Revenue for the twelve months ended 30 September 2015 of £28.5 million ($43.2 million) compared to £30.0 million for the twelve months ended 30 September 2014
  • Loss for the twelve months ended 30 September 2015 of £44.6 million ($67.4 million) compared to £14.7 million for the twelve months ended 30 September 2014
  • Cash and cash equivalents at 30 September 2015 of £234.9 million ($355.3 million) compared to £164.5 million as at 30 September 2014. (Original Source)

Shares of GW Pharmaceuticals are down 1.48% to $81.02. GWPH has a 1-year high of $133.98 and a 1-year low of $65.28. The stock’s 50-day moving average is $83.90 and its 200-day moving average is $104.51.

On the ratings front, GW Pharmaceuticals has been the subject of a number of recent research reports. In a report issued on October 15, Piper Jaffray analyst Joshua Schimmer reiterated a Buy rating on GWPH, with a price target of $147, which represents a potential upside of 72.9% from where the stock is currently trading. Separately, on September 17, Cowen’s Phil Nadeau reiterated a Buy rating on the stock and has a price target of $135.

According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Joshua Schimmer and Phil Nadeau have a total average return of -1.0% and 13.6% respectively. Schimmer has a success rate of 42.4% and is ranked #2885 out of 3645 analysts, while Nadeau has a success rate of 57.9% and is ranked #268.

GW Pharmaceuticals PLC is engaged in the research, development and commercialisation of cannabinoid prescription medicines to meet patient needs.